Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | MYSENTRY SYSTEM, MYSENTRY MONITOR, MYSENTRY OUTPOST |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S157 |
Date Received | 06/18/2014 |
Decision Date | 07/18/2014 |
Product Codes |
MDS OYC |
Advisory Committee |
Clinical Chemistry |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITION OF A FUNCTIONAL TEST DURING MANUFACTURE OF THE MYSENTRY SYSTEM (MMT-9100). THE MYSENTRY SYSTEM (MMT-9100) CONSISTS OF THE MYSENTRY MONITOR (MMT-9101) AND MYSENTRY OUTPOST (MMT-9102) AND IS APPROVED FOR USE WITH THE PARADIGM REALTIME REVEL SYSTEM. |
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